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Prevalence of Frailty in Patients With a Cardiovascular Disease and Correlations With Markers of Exercise

Prevalence of Frailty in Patients With a Cardiovascular Disease and Correlations With Markers of Exercise

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04206904
Enrollment
140
Registered
2019-12-20
Start date
2019-11-25
Completion date
2020-06-23
Last updated
2020-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty

Keywords

older adults, cardiovascular diseases, maximal exercise test

Brief summary

In the first part of this study the prevalence of frailty in patients with cardiovascular disease will be examined. Frailty is defined as a progressive age-related decline in physiological systems that results in decreased reserves of intrinsic capacity, which confers extreme vulnerability to stressors. Patients (≥65 years, men and women) suffering from heart failure or undergoing a coronary artery bypass grafing (CABG) or percutaneous coronary intervention (PCI) will be included. Based on the phenotype of Fried, frailty will be examined in the physical domain. Moreover, the nutritional, social, psychological and cognitive domain of frailty will be examined. This will result in a total score of 0 (no frailty) to 24 (severe frailty), divided into four categories: no frailty (score 0-6), minor frailty (score 7-12), moderate frailty (score 13-18) or severe frailty (score 18-24). Besides this frailty protocol, a few other measurements will be completed to collect additional information about the functioning of the patient. At discharge from the hospital, some of these patients will start with a cardiac rehabilitation program. To define the exercise intensity of this program, patients will perform a maximal exercise test (CPET). In the second part of this study, correlations will be examined between markers of frailty and markers of exercise from the CPET (e.g. maximal heart rate, maximal oxygen uptake).

Interventions

None listed

Sponsors

Hasselt University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Men and women with an age of at least 65 years at the start of the study; Staying in Jessa Hospital for PCI, CABG or heart failure

Exclusion criteria

A persistently unstable clinical condition at baseline visit (angina, advanced conduction disturbances, threatening ventricular arrhythmias, acute heart failure, clinical condition requiring interventions such as acute renal failure, Hb \<9,0 mg/dl, presence of end-stage disease or the lack of informed consent to study participation)

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of functional lower limb strengthAt baselineEvaluation of functional lower limb strength of the patient via the Timed Chair Stand Test
Level of (in)dependence via the Katz scaleAt baselineEvaluation of the level of (in)dependence in activities of daily life via a 4-point scale (1-4)
Nutritional status via the Mini Nutritional Assessment (MNA)At baselineExamination of the nutritional status of the patient via a questionnaire (30 points)
Level of physical activity via the International Physical Activity Questionnaire (IPAQ)At baselineExamination of the level of physical activity of the patient via a questionnaire
Cognitive status via the Mini Mental State Examination (MMSE)At baselineExamination of the cognitive status of the patient via a short screening (30 points)
Psychological status via the Geriatric Depression Scale (GDS-15)At baselineExamination of the presence/absence of a depressive mood via a questionnaire (15 questions/15 points)
Concern about falling via the Falls Efficacy Scale (FES-I)At baselineExamination of the level of concern about falling during social and physical activities via a questionnaire (16 questions/ 64 points)
Weight loss via the evaluation of body weightAt baselineEvaluation of involuntary loss of body weight in the previous months
Gait speed via the 4.6 meter walking testAt baselineExamination of the walking speed of the patient
Evaluation of handgrip strengthAt baselineEvaluation of the handgrip strength of the patient via handheld dynamometry
Examination of mobility/balance/muscle strength/risk of falling via the Timed Up and Go Test (TUG)At baselineThe Timed Up and Go Test measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. By combining this test with a motor or cognitive dual task, the risk of falling of the patient will be examined.
Comorbidities via the record of medication useAt baselineRecord of cardiac and other medications
Evaluation of lower limb strengthAt baselineEvaluation of lower limb strength of the patient via Microfet measurements

Secondary

MeasureTime frameDescription
Correlations between frailty (via the primary frailty outcome measures) and exercise parameters (via the maximal exercise test (CPET)At the start of the cardiac rehabilitation programEvaluation of correlations between frailty characteristics (from the primary outcome measures) and exercise parameters from a maximal exercise test (CPET) (performed at the start of a cardiac rehabilitation program).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026